Design Quality Engineer

Smith Nephew; Austin (TX); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Paid Holidays

Flexible Personal/Vacation Time Off

Job summary

Smith+Né is seeking a Design Quality Engineer in Austin, TX to support design controls, verification and validation, and risk management for ENT products from concept through development. You will collaborate across functions to ensure products meet regulatory requirements and quality standards.

Applicants should have a Bachelor’s degree in Engineering and up to 2 years of medical device experience, with knowledge of FDA CFR 820, ISO 13485, and GxP.

Qualifications

• Bachelor's degree in Engineering or related field.
• 0–2 years of experience in medical devices or related industry with basic understanding of design controls.
• Strong communication and Excel skills; familiarity with AI tools is a plus.

Responsibilities

• Support design controls and quality activities, including verification and validation, sterilization validation, process validation, supplier qualification, test methods, capability studies and risk management documentation.
• Develop methods and procedures to ensure products meet specifications with safety and reliability through testing.
• Support manufacturing with product requirements, risk management, test methods and statistical analysis.
• Help ensure compliance with cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR requirements.
• Coordinate with external labs and suppliers to communicate requirements and assess capabilities.
• Assist continuous improvement activities, including CAPA, nonconformance and internal audits.
• Contribute to Post Market Surveillance, Management Review and audit activities.

Skills

Design Controls

FDA CFR 820

ISO 13485

GxP

Excel

AI tools

Education

Bachelor's degree in Engineering

Job description

Life. Unlimited. At Smith+Né Join our ENT New Product Development team as a Design Quality Engineer in Austin WC, where you will help bring safe, reliable medical device technologies from concept through development. This is an opportunity to build your quality engineering expertise while partnering across functions and helping ensure new products meet rigorous quality and regulatory requirements.

What will you be doing?

• Support design controls and quality activities, including design verification and validation, sterilization validation, process validation, supplier qualification, test methods, capability studies and risk management documentation.
• Develop methods and procedures that help ensure products meet required specifications and standards, with product safety and reliability established through appropriate testing.
• Support manufacturing operations with expertise in product requirements, risk management, test methods and statistical analysis.
• Help ensure compliance with applicable quality and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR requirements.
• Partner with external laboratories and suppliers to communicate product and process requirements and assess capabilities.
• Support continuous improvement activities, including CAPA, nonconformance and internal audit activities.
• Contribute to Post Market Surveillance, Management Review and audit and inspection activities.

What will you need to be successful?

• Bachelor's degree in Engineering.
• 0 to 2 years of experience in the medical device or a related industry, with a general or basic understanding of Design Control and requirements such as FDA CFR 820, ISO 13485, EU MDR and GxP.
• Ability to manage and prioritize multiple projects, tasks and deadlines while working effectively as part of a team.
• Effective written and verbal communication skills, with proficiency in Excel and AI tools.
• A statistical background is preferred.
• Ability to travel less than 5%

Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization.

You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website.
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

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Smith+Né provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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